(88 days)
Victan is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
The Single Use Surgical Electrocoagulator is a sterile, single-patient-use electrosurgical accessory, and deliver electrical current from high-frequency generator to the surgical site. At the same time, the product can also provides suction or irrigation by connecting to a negative pressure drainage device. The proposed product consists of Electrode, External tube, Irrigation and suction tube, External tube control button, Rotator, Irrigation switch, Suction switch, Handle, Suction connecting tube, Suction connector, Irrigation connector, Cable, Irrigation connecting tube, Outer tube.
The provided text describes the 510(k) summary for the Victan Single Use Surgical Electrocoagulator (K230593). This document outlines the device performance data provided to support its substantial equivalence to a predicate device.
It's important to note that this 510(k) summary does NOT involve an AI/ML powered device, and therefore, many of the requested elements pertaining to AI model performance (like sample size for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance) are not applicable. The device is a traditional electrosurgical accessory.
However, I can extract the relevant acceptance criteria and the study that proves the device meets those criteria, based on the information provided.
Device: Victan Single Use Surgical Electrocoagulator (K230593)
Device Type: Electrosurgical Accessory (not an AI/ML device)
1. Table of acceptance criteria and the reported device performance:
Since this is a physical medical device and not an AI/ML algorithm, the "acceptance criteria" are typically defined by compliance with recognized standards and successful performance in bench testing. The "reported device performance" refers to the results demonstrating this compliance.
| Acceptance Criteria (Defined by standards compliance and functional requirements) | Reported Device Performance (Study Results) |
|---|---|
| Biocompatibility: Device materials are biologically safe for human contact. | Study: Tests conducted according to ISO10993-1. Results: Evaluated and confirmed safe for: - Cytotoxicity - Sensitization - Intracutaneous Reactivity - Acute Systemic Toxicity - Material-Mediated Pyrogenicity |
| Electrical Safety: Device operates safely with regard to electrical hazards. | Study: Electrical safety testing. Results: Complies with relevant clauses of IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) and IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment). |
| Electromagnetic Compatibility (EMC): Device does not interfere with or is not interfered by other electronic devices. | Study: EMC testing. Results: Complies with IEC 60601-1-2 (Collateral Standard: Electromagnetic disturbances - Requirements and tests). |
| Sterilization: Device is effectively sterilized and maintains sterility. | Study: Sterilization validation. Results: Sterilized by Ethylene Oxide (EO) to the same sterility assurance level as the predicate device. Valid period of sterilization confirmed as 3 years. |
| Shelf-life: Device maintains performance and sterility over time. | Study: Accelerated Aging testing. Results: Confirmed an expiration date of 3 years from the manufacturing date. |
| Bench Performance: Device meets design specifications for physical properties and essential functions. | Study: Bench testing. Results: Device applicable to specifications and demonstrated to be safe and effective for: - Appearance - Dimension - Leakage - Pressure Resistance - Continuity - Irrigation and Suction Flow - Tensile Strength |
Regarding the other requested information (primarily for AI/ML devices):
2. Sample sized used for the test set and the data provenance: Not applicable. For a physical device, testing involves functional and safety evaluations on device units, not a "test set" of data in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and medical device standards, and direct measurement/testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to human review of AI outputs.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was done, as this is not an AI-assisted device. The "comparison" is to a legally marketed predicate device, demonstrating substantial equivalence based on technical characteristics, indications for use, and performance data, not an improvement in human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established by:
* Compliance with recognized industry standards (e.g., ISO, IEC).
* Direct physical and electrical measurements (e.g., dimension, electrical safety tests).
* Functional tests (e.g., leakage, flow rates).
* Material properties assessment (e.g., biocompatibility testing).
8. The sample size for the training set: Not applicable. There is no training set as it's not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. There is no training set. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and medical device regulations.
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May 30, 2023
Jiangsu Haize Medical Scientific Development Co., Ltd. Vincy Gao RA No.99, Furongzhongsan Road, Xishan Economical Development Zone Wuxi, Jiangsu 214000 China
Re: K230593
Trade/Device Name: Victan Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: May 9, 2023 Received: May 9, 2023
Dear Vincy Gao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Mark Trumbore -S. The date of the signature is 2023.05.30. The time of the signature is 10:01:30 -04'00'.
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230593
Device Name Victan
Indications for Use (Describe)
Victan is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Single Use Surgical Electrocoagulator
| Compiled by: | Vincy Gao |
|---|---|
| Date: | 2023.01.02 |
| Reviewed by: | Zhang Rong |
| Date: | 2023.01.16 |
| Approved by: | Qian Jianmin |
| Date: | 2023.02.15 |
Jiangsu Haize Medical Scientific Development Co.,Ltd
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510(k) Summary
1. Submitter Information
| Applicant/Submitter: | Jiangsu Haize Medical Scientific Development Co.,Ltd. |
|---|---|
| No.99, Furongzhongsan Road, Xishan Economical | |
| Development Zone, Wuxi, Jiangsu, China | |
| Phone: 086-0510-82833301 | |
| Fax: 086-0510-82833301 | |
| Contact Person: | Vincy Gao |
| chenll@haizemed.net |
2. Device
| Trade Name | Victan |
|---|---|
| Common Name | Single Use Surgical Electrocoagulator |
| Classification Name | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number | 21 CFR 878.4400 |
| Device Class | Class II |
| Product Code | GEI |
| 510(K) Number | K230593 |
3. Predicate Device
| Manufacturer | Product Name | 510(K) Number |
|---|---|---|
| Sejong Medical Co., Ltd. | LAP-iX | K173112 |
4. Device Description
The Single Use Surgical Electrocoagulator is a sterile, single-patient-use electrosurgical accessory, and deliver electrical current from high-frequency generator to the surgical site. At the same time ,
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the product can also provides suction or irrigation by connecting to a negative pressure drainage device. The proposed product consists of Electrode, External tube, Irrigation and suction tube, External tube control button, Rotator, Irrigation switch, Suction switch, Handle, Suction connecting tube, Suction connector, Irrigation connector, Cable, Irrigation connecting tube, Outer tube.
Single Use Surgical Electrocoagulator should be operated with HF generators having a nominal frequency of the HF voltage between 300 kHz and 3 MHz. Lower frequencies may cause nerve stimulation and thus uncontrolled convulsion. In case of higher frequencies, user/patient safety cannot be guaranteed because insulation may heat up so that dielectric strength is no longer given. All equipment conforming to this specs can be used.
The product was sterilized by EO. The valid period of sterilization was 3 years.
5. Indications for Use
Single Use Surgical Electrocoagulator is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
| Item | Proposed Device | Predicate Device | Equivalence |
|---|---|---|---|
| Trade Name | Victan | LAP-iX | / |
| Manufacturer | Jiangsu Haize MedicalScientific DevelopmentCo.,Ltd. | Sejong Medical Co., Ltd. | / |
| Classification Name | Electrosurgical, cutting &coagulation device &accessories | Electrosurgical, cutting &coagulation device &accessories | Same |
| 510(K) Number | K230593 | K173112 | / |
| Device Class | Class II | Class II | Same |
| Product Code | GEI | GEI | Same |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Indications for Use | Single Use SurgicalElectrocoagulator is asterile, single-patient-useelectrosurgical accessoryintended to conductelectrosurgical currentfor cutting andcoagulation of tissueand/or to provide suctionand irrigation functions | Single Use SurgicalElectrocoagulator is asterile, single-patient-useelectrosurgical accessoryintended to conductelectrosurgical currentfor cutting andcoagulation of tissueand/or to provide suctionand irrigation functions | Same |
6. Comparison of Technological Characteristics with the Predicate Device
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| to the surgical site. | to the surgical site. | ||
|---|---|---|---|
| Energy Type | Radiofrequency | Radiofrequency | Same |
| Electrode Type | Monopolar | Monopolar | Same |
| End-tip Type | Angle, Spade, Hook, Needle | L-hook,Spoon | Different(After the assessment,End-tip type does notaffect electrical safety orperformance.) |
| Handle Type | Pistol Type, Trumpet Type | Pistol Type, Trumpet Type | Same |
| Length | Function TubeLength:190/335/435mm | Tip Length:37/48cm | Different(After the assessment,End-tip type does notaffect electrical safety orperformance.) |
| Materials(Electrode) | Stainless steel | Stainless steel | Same |
| Sterilization | EO | EO | Same |
| Performance Test | Appearance, Dimension,Leakage, PressureResistance, Continuity,Irrigation and SuctionFlow, Tensile Strength,Electrical safety andelectromagneticcompatibility (EMC) | Nominal size, Leakage,Continuity,Dielectric Strength Testof Electrode cable, HFLeakage current Test ofElectrodecable, and TensileStrength Test ofElectrode cable | Equivalent(The actual test resultsare the same.) |
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
7.1. Biocompatibility
The device has been evaluated for its biological safety according to ISO10993-1 Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk Management Process. Following endpoints have assessed during the evaluation:
-
- Cytotoxicity
-
- Sensitization
-
- Intracutaneous Reactivity
-
- Acute Systemic Toxicity
-
- Material-Mediated Pyrogenicity
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7.2. Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Single Use Surgical Electrocoagulator. The subject device complies with relevant clauses of the IEC 60601-1, IEC-60601-2-2 standards for safety and the IEC 60601-1-2 for EMC.
7.3. Sterilization
The subject device and the predicate device are sterilized via Ethylene Oxide; both devices are sterilized to the same sterility assurance level.
7.4. Shelf-life
Accelerated Aging testing confirmed that the expiration date of subject device is 3 year from the manufacturing date.
7.5. Bench Testing
Haize Medical conducted bench testing to ensure that the design of Single Use Electrocoagulator applicable the specifications and that the product is safety and effective in use.
Test included:
- Appearance
- Dimension
- Leakage ●
- Pressure Resistance
- Continuity
- Irrigation and Suction Flow
- Tensile Strength
7.6. Animal Study
This premarket notification does not rely on preclinical animal testing to demonstrate substantial equivalence.
7.7. Clinical Study
This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
8. Substantial Equivalence
The subject and predicate device have the same fundamental technology and indications for use. The performance, dimensions and materials of the subject device are similar to the predicate device. Although there some minor differences with each product, these differences between the subject device and the predicate device do not raise new or different questions of safety and efficacy. There is no new technology and no difference that would raise new or different questions of safety or efficacy.
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9. Conclusion
The subject device are identical in intend use, indications and technology compared to the predicate device. The results of the test demonstrate that the subject devices do not raise new questions of safety and effectiveness and are substantially equivalent to the predicate devices.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.